Phase II Study Assessing the Efficacy and Safety of Lenvatinib for Anaplastic Thyroid Cancer
Status:
Completed
Trial end date:
2020-03-20
Target enrollment:
Participant gender:
Summary
The purpose of this phase Ⅱ study is to assess the efficacy and safety of lenvatinib for
anaplastic thyroid cancer patients who are diagnosed as unresectable. The total duration of
the study will be 30 months. All patients will start administration of lenvatinib within 1
week of enrollment and receive the study drug 24mg orally once daily at almost the same time.
1 cycle consists of 4 weeks. Treatment term starts on the day 1st of drug administration of
cycle 1 and administration will be continued until patients meet withdrawal criteria. Safety
and efficacy assesment will be conducted on a regular basis during the trial. Tumor
evaluation will be conducted at 4weeks, 8 weeks, 12 weeks, 16 weeks and at every 8 weeks
after the 16th week since initial administration. When study drug administration
terminated,tests of the drug termination will be conducted within 7 days of withdrawal and
final observation will be conducted at 30 days after the last dose. Survival survey will be
conducted at follow-up term. After the termination of the study drug, survival follow up
survey will be conducted every 12 weeks unless patients withdraw enrollment of this study.
Phase:
Phase 2
Details
Lead Sponsor:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan Translational Research Informatics Center, Kobe, Hyogo, Japan